Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Department of Health (DH) today (21 Apr) drew users’ attention to a Field Safety Notice related to the Philips Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, Trilogy EV300.
According to the manufacturer, it has detected environmental debris (e.g., external dust and dirt) in the air path of some devices. Extended exposure to these environmental debris can lead to buildup of particulate on the internal flow sensor within the device which may cause it to inaccurately deliver pressure, volume, or flow. This may lead to barotrauma, volutrauma, hypoventilation, hypercapnia or if unaddressed hypoxemia.
The manufacturer advised the followings:-
According to the notice, it will replace the machine flow sensor of impacted devices meeting the following criteria:-
According to the local supplier, the device is distributed in Hong Kong.
If you are in possession of the affected products, please contact the supplier for necessary actions.
Posted on 21 Apr 2023